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Laparoscopic Ventral Hernia Repair With Elastomeric Pain Pump

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ClinicalTrials.gov Identifier: NCT00472134
Recruitment Status : Completed
First Posted : May 11, 2007
Last Update Posted : June 8, 2015
Information provided by (Responsible Party):
Michael J. Rosen, MD., University Hospitals Cleveland Medical Center

Brief Summary:

The purpose of this study is to determine the effects of a local anesthetic dispensed via a tiny catheter device, called the ON-Q PainBuster pump, placed during surgery on top of the mesh used in the laparoscopic repair of ventral hernias. The goals are:

  • reducing postoperative pain from this procedure
  • decreasing length of hospital stay
  • reducing or eliminating amount of post-operative narcotics used

Condition or disease Intervention/treatment Phase
Hernia, Ventral Drug: bupivacaine Device: On-Q PainBuster pump Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Double-blind Trial of Continuous Infusion of 0.5% Bupivacaine be Elastomeric Pump for Prospective Pain Management After Laparoscopic Ventral Hernia Repair.
Study Start Date : December 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Active Comparator: Bupivicaine via Elastomeric pump
Bupivicaine via elastomeric pump
Drug: bupivacaine
administered locally, 0.5% Bupivacaine (Marcaine Abbott Laboratories) or saline administered continuously for 48 hours at 2 mL/h.
Other Name: Marcaine

Placebo Comparator: Placebo via elastomeric pump
Placebo via elastomeric pump
Device: On-Q PainBuster pump
local anesthetic (bupivacaine) administered via a pain relief system consisting of a 20 gauge soaker catheter attached to an elastomeric balloon pump that is capable of infusing a set volume of local anesthetic over a wide area of surgical site for 2 to 5 days

Primary Outcome Measures :
  1. Place an elastomeric infusion catheter superficial to the mesh at the conclusion of the laparoscopic ventral hernia repair and compare the following to a group that receives a placebo infusion of saline: [ Time Frame: 3 months ]
  2. Measuring: Visual Analog Pain Scale, Short-Form McGill Pain Questionnaire, Present Pain Intensity, Quantity of narcotic consumption [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Assess differences in postoperative pulmonary mechanics between the treated and nontreated groups by measuring the changes in maximal inspiratory volumes from baseline. [ Time Frame: 3 months ]
  2. The return of bowel function: Day of Flatus, Tolerating Regular Diet, Length of hospital stay [ Time Frame: 1 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Laparoscopic ventral hernia repair
  • Consent obtained

Exclusion Criteria:

  • Under 18 years
  • Allergic to Bupivacaine
  • significant liver or renal disease
  • Contraindication to PCA
  • Current daily opioid usage
  • History of substance abuse disorders
  • Dx of chronic pain syndrome
  • Daily usage of NSAIDs or COX 2 inhibitors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00472134

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United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
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Principal Investigator: Michael J. Rosen, MD University Hospitals Cleveland Medical Center
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Responsible Party: Michael J. Rosen, MD., Principal Investigator, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT00472134    
Other Study ID Numbers: 11-05-22
First Posted: May 11, 2007    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: January 2012
Keywords provided by Michael J. Rosen, MD., University Hospitals Cleveland Medical Center:
Laparoscopic Hernia Repair
Additional relevant MeSH terms:
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Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents